Single Blinded Randomized Controlled Trial on BNT162b2 or mRNA-1273 (mRNA) vs Ad26COVS1 or ChAdOx1-S (Viral Vector) for Third Vaccination in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Seroconversion at 4 weeks
研究概览
简要总结
Randomized-controlled trial comparing homologous (mRNA vaccine) vs. heterologous (vector vaccine) for third SARS-CoV-2 vaccine dose in kidney transplant recipients not responding to initial prime-boost vaccination with an mRNA vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient has received a kidney transplantation
- •full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening
- •> 18 years of age
- •no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine
排除标准
- •acute illness with fever
- •Prior documented infection with SARS-CoV-2
- •triple anticoagulation therapy
- •Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
- •Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
- •Subject is pregnant or breast feeding
研究组 & 干预措施
homologous 3rd vaccination (mRNA vaccine)
Participants will receive a third SARS-CoV-2 vaccination with the same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 )
干预措施: BNT162B2 (Drug)
homologous 3rd vaccination (mRNA vaccine)
Participants will receive a third SARS-CoV-2 vaccination with the same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 )
干预措施: mRNA-1273 (Drug)
heterologous 3rd vaccination (vector vaccine)
participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)
干预措施: Ad26COVS1 (Drug)
heterologous 3rd vaccination (vector vaccine)
participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)
干预措施: ChAdOx1 SARS2 Vaccine (Drug)
结局指标
主要结局
Seroconversion at 4 weeks
时间窗: 4 weeks
number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination
次要结局
- SARS-CoV-2 antibody levels at 12 weeks(3 months)
- Seroconversion at 36 weeks(6 months)
- Seroconversion at 12 weeks(3 months)
- SARS-CoV-2 antibody levels at 4 weeks(4 weeks)
研究者
Roman Reindl-Schwaighofe
Principal Investigator
Medical University of Vienna